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Catalent accused of using shortcuts in COVID vaccine production

By Sara Molina

Posted August 23, 2023

Catalent

Bloomington's Catalent is one of two key locations facing accusations. (Courtesy: Catalent/City of Bloomington)

Current and former Catalent board members have been accused of short-handing production regulations and providing inaccurate information about the company’s business and financial status in a shareholder derivative lawsuit.

The suit, Husky v. Catalent Inc., was filed in the US District Court for the District of Delaware on Aug. 11. It focuses on COVID-19 related products the drug manufacturing company pushed out between August 30, 2021 and October 31, 2022. 

Catalent experienced rapid growth at the beginning of the pandemic, working on over 100 COVID-related products for customers at key facilities in Bloomington and Brussels, Belgium.

In an effort to keep up with this increasing demand, the company was accused of “cutting corners on safety and control procedures at its key production facilities,” drawing the FDA’s attention. 

The FDA cited the company for “bacterial growth, faulty air filtration systems, subpar equipment maintenance, and control procedure problems.” Because of these contaminations, millions of COVID vaccine booster shots filled by Catalent were delayed.

Read more: Layoffs mean Catalent unlikely to receive city tax abatement

During this time, the company was also making false public statements about its adherence to regulatory rules. 

Production issues are on-going. Bloomington’s Catalent location was reinspected this April and May, resulting in a Form FDA 483, meaning violations were found.

As vaccine demand began to decrease, Catalent’s senior management kept reporting revenues with constant inflation. However, it sold more vaccines to direct buyers like Pfizer and Johnson & Johnson than they could provide to end consumers, according to shareholders. 

Once the company announced that the vaccine demand was falling, a 7.4% stock decrease immediately followed. Despite this, the lawsuit documents that defendants continued to release misleading statements about Catalent’s revenue and product demand and the company has been charged.

The company has not responded at this time.

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